On one hand, I think the FDA shouldn’t be gatekeeping as much as it does. The ideal, I think, would be if they were reduced to an advisory role, where they published an opinion on which drugs are good, and that opinion had some influence on insurers’ willingness to pay and doctors’ willingness to prescribe, but had no legal force.
However, an Alzheimer’s drug is one where, by definition, most of the relevant patient population can’t evaluate the evidence themselves. So under a relaxing-standards interpretation, this is a very bad choice for where to relax the requirements first. And under the normal interpretation of what FDA approvals mean, this is just straight-up lying.
On one hand, I think the FDA shouldn’t be gatekeeping as much as it does. The ideal, I think, would be if they were reduced to an advisory role, where they published an opinion on which drugs are good, and that opinion had some influence on insurers’ willingness to pay and doctors’ willingness to prescribe, but had no legal force.
However, an Alzheimer’s drug is one where, by definition, most of the relevant patient population can’t evaluate the evidence themselves. So under a relaxing-standards interpretation, this is a very bad choice for where to relax the requirements first. And under the normal interpretation of what FDA approvals mean, this is just straight-up lying.